Elderly patients with dementia-related psychosis
treated with antipsychotic drugs are at an increased risk of death. ABILIFY
MYCITE is not approved for the treatment of patients with dementia-related
psychosis [see WARNINGS AND PRECAUTIONS].

Suicidal Thoughts and Behaviors

Antidepressants increased the risk of suicidal
thoughts and behaviors in pediatric and young adult patients in short-term
studies. Closely monitor all antidepressanttreated patients for clinical
worsening, and for emergence of suicidal thoughts and behaviors [see WARNINGS
AND PRECAUTIONS]. The safety and efficacy of ABILIFY MYCITE have not been
established in pediatric patients [see Use In Specific Populations].

The ABILIFY MYCITE System is a drug-device combination
product composed of the following components:

An aripiprazole tablet with an embedded Ingestible Event
Marker (IEM) sensor. The IEM is a 1 mm sized sensor embedded in the ABILIFY
MYCITE tablet. Upon contact with gastric fluid, magnesium and cuprous chloride
within the IEM react to activate and power the device. The IEM then communicates
to the MYCITE Patch, to track aripiprazole ingestion.

A MYCITE Patch (wearable sensor) is designed to detect
the ingestion of the ABILIFY MYCITE tablet, record the ingestion of the IEM,
and transmit ingestion data to the mobile patient application (app).

A compatible mobile patient application (app) displays
this data to allow patients to review their medication ingestion. These data
can be shared with healthcare providers and caregivers.

Maintenance treatment of adults as monotherapy and as
adjunct to lithium or valproate [see Clinical Studies]

Adjunctive treatment of adults with Major Depressive
Disorder [seeClinical Studies]

Limitations Of Use

The ability of the ABILIFY MYCITE to improve patient
compliance or modify aripiprazole dosage has not been established [see DOSAGE
AND ADMINISTRATION].

The use of ABILIFY MYCITE to track drug ingestion in
“real-time” or during an emergency is not recommended because detection may be
delayed or not occur [see DOSAGE AND ADMINISTRATION].

DOSAGE AND ADMINISTRATION

Overview Of The ABILIFY MYCITE System

The ABILIFY MYCITE System is composed of the following
components:

Aripiprazole tablet embedded with an IEM sensor (ABILIFY
MYCITE);

MYCITE® Patch (wearable sensor) that detects the signal
from the IEM sensor after ingestion and transmits data to a smartphone;

MYCITE APP - a smartphone application (app) which is used
with a compatible smartphone to display information for the patient;

Web-based portal for healthcare professionals and
caregivers

Prior to initial patient use of the ABILIFY MYCITE
System, facilitate use of the combination product and its components (patch,
app, portal) and ensure the patient is capable and willing to use smartphones and
apps. Before using any component of the ABILIFY MYCITE System, instruct
patients to:

Download the MYCITE APP and follow all the Instructions
for Use.

Ensure that the app is compatible with their specific
smartphone

Although most ingestions will be detected within 30
minutes, it may take up to two hours for the smartphone app and web portal to
detect the ingestion of ABILIFY MYCITE; in some cases, the ingestion of the
tablet may not be detected. If the tablet is not detected after ingestion, do
not repeat the dose [see ADVERSE REACTIONS].

The status of the MYCITE Patch is indicated by a status
icon in the app to inform the user that the patch is properly adhered and fully
functioning. Instruct patients to ensure that the app is paired with the patch prior
to use. Refer to the information provided in the product packaging and
electronic Instructions for Use within the MYCITE APP.

Administration Instructions

ABILIFY MYCITE

Administer ABILIFY MYCITE orally with or without food [see
CLINICAL PHARMACOLOGY]. Swallow tablets whole; do not divide, crush, or
chew.

MYCITE Patch

Apply the MYCITE Patch only when instructed by the app to
the left side of the body just above the lower edge of the rib cage. Do not
place the MYCITE Patch in areas where the skin is scraped, cracked, inflamed,
or irritated, or in a location that overlaps the area of the most recently
removed patch. Instruct patients to keep the patch on when showering, swimming,
or exercising. The MYCITE Patch should be changed weekly or sooner as needed.
The app will prompt patient to change the patch and will direct patient to
apply and remove the patch correctly. Patients undergoing an MRI need to remove
their patch and replace with a new one as soon as possible. If there is skin
irritation, instruct patients to remove the patch.

Dosage In Schizophrenia

The recommended starting and target dosage for ABILIFY
MYCITE in adults with schizophrenia is 10 or 15 mg daily. Dosage increases
should generally not be made before 2 weeks [see CLINICAL PHARMACOLOGY].
The maximum recommended dosage is 30 mg daily; however, doses above 15 mg daily
have shown no additional clinically meaningful benefit.

Dosage In Bipolar I Disorder

The recommended starting dosage in adults with acute and
mixed episodes associated with bipolar I disorder is 15 mg given once daily as
monotherapy and 10 mg to 15 mg given once daily as adjunctive treatment with
lithium or valproate. The recommended target dose of ABILIFY MYCITE is 15 mg
daily, as monotherapy or as adjunctive treatment with lithium or valproate. The
dosage may be increased to 30 mg daily based on clinical response. The maximum
recommended daily dosage is 30 mg.

Dosage In Adjunctive Treatment Of Major Depressive
Disorder

The recommended starting dose for ABILIFY MYCITE as
adjunctive treatment of adults with MDD taking an antidepressant is 2 to 5 mg
daily. The recommended dosage range is 2 to 15 mg daily. Dosage adjustments of
up to 5 mg daily should occur gradually, at intervals of no less than 1 week.
The maximum recommended daily dosage is 15 mg. Periodically reassess to
determine the continued need for maintenance treatment.

Dosage Adjustments For Cytochrome P450 Considerations

Dosage adjustments are recommended in patients who are
known CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4
inhibitors or CYP2D6 inhibitors or strong CYP3A4 inducers (see Table 1). When
the co-administered drug is withdrawn from the combination therapy, ABILIFY MYCITE
dosage should then be adjusted to its original level. When the co-administered
CYP3A4 inducer is withdrawn, ABILIFY MYCITE dosage should be reduced to the
original level over 1 to 2 weeks. Patients who may be receiving a combination
of strong, moderate, and weak inhibitors of CYP3A4 and CYP2D6 (e.g., a strong
CYP3A4 inhibitor and a moderate CYP2D6 inhibitor or a moderate CYP3A4 inhibitor
with a moderate CYP2D6 inhibitor), the dosing may be reduced to one-quarter
(25%) of the usual dose initially and then adjusted based on clinical response.

When adjunctive ABILIFY MYCITE is administered to
patients with major depressive disorder, ABILIFY MYCITE should be administered
without dosage adjustment as specified in [Dosage in Adjunctive Treatment of Major Depressive Disorder].

HOW SUPPLIED

Dosage Forms And Strengths

ABILIFY MYCITE (aripiprazole tablets with sensor) is
available as described in Table 2.

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in practice.

The safety of ABILIFY MYCITE for the treatment of adults
with schizophrenia, treatment of adults with manic and mixed episodes
associated with bipolar I disorder, and adjunctive treatment of adults with major
depressive disorder (MDD) has been established and is based on trials of
aripiprazole including 13,543 adult patients who participated in multiple-dose,
clinical trials in schizophrenia, bipolar disorder, major depressive disorder,
and other disorders, and who had approximately 7619 patient-years of exposure
to oral aripiprazole. A total of 3390 patients were treated with oral
aripiprazole for at least 180 days and 1933 patients treated with oral
aripiprazole had at least 1 year of exposure.

The conditions and duration of treatment with
aripiprazole (monotherapy and adjunctive therapy with antidepressants or mood
stabilizers) included (in overlapping categories) double-blind, comparative and
noncomparative open-label studies, inpatient and outpatient studies, fixed- and
flexible-dose studies, and short- and longer-term exposure.

The most common adverse reactions of aripiprazole in
adult patients in clinical trials (≥10%) were nausea, vomiting,
constipation, headache, dizziness, akathisia, anxiety, insomnia, and
restlessness.

Adverse Reactions In Adult Patients With Schizophrenia

The following findings are based on a pool of five
placebo-controlled trials (four 4-week and one 6-week) in which oral
aripiprazole was administered in doses ranging from 2 to 30 mg/day.

The commonly observed adverse reaction associated with
the use of aripiprazole tablets in patients with schizophrenia (incidence of 5%
or greater and aripiprazole tablets incidence at least twice that for placebo)
was akathisia (aripiprazole tablets 8%; placebo 4%).

Adverse Reactions In Adult Patients With Bipolar Mania

Adult Patients Who Received Monotherapy

The following findings are based on a pool of 3-week,
placebo-controlled, bipolar mania trials in which oral aripiprazole was
administered at doses of 15 or 30 mg/day.

Commonly observed adverse reactions associated with the
use of aripiprazole tablets in patients with bipolar mania (incidence of 5% or
greater and aripiprazole tablets incidence at least twice that for placebo) are
shown in Table 9.

Table 10 enumerates the pooled incidence, rounded to the
nearest percent, of adverse reactions that occurred during acute therapy (up to
6 weeks in schizophrenia and up to 3 weeks in bipolar mania), including only
those reactions that occurred in 2% or more of patients treated with aripiprazole
tablets (doses ≥2 mg/day) and for which the incidence in patients treated
with aripiprazole tablets was greater than the incidence in patients treated
with placebo in the combined dataset.

aAdverse reactions reported by at least 2% of
patients treated with oral aripiprazole, except adverse reactions which had an
incidence equal to or less than placebo.

An examination of population subgroups did not reveal any
clear evidence of differential adverse reaction incidence on the basis of age,
gender, or race.

Adult Patients With Adjunctive Therapy With Bipolar
Mania

The following findings are based on a placebo-controlled
trial of adult patients with bipolar disorder in which aripiprazole tablets was
administered at doses of 15 or 30 mg/day as adjunctive therapy with lithium or
valproate.

In a study of patients who were already tolerating either
lithium or valproate as monotherapy, discontinuation rates due to adverse
reactions were 12% for patients treated with adjunctive aripiprazole tablets
compared to 6% for patients treated with adjunctive placebo. The most common
adverse drug reactions associated with discontinuation in the adjunctive aripiprazole-treated
compared to placebotreated patients were akathisia (5% and 1%, respectively)
and tremor (2% and 1%, respectively).

The commonly observed adverse reactions associated with
adjunctive aripiprazole tablets and lithium or valproate in patients with
bipolar mania (incidence of 5% or greater and incidence at least twice that for
adjunctive placebo) were: akathisia, insomnia, and extrapyramidal disorder.

Table 11 enumerates the incidence, rounded to the nearest
percent, of adverse reactions that occurred during acute treatment (up to 6
weeks), including only those reactions that occurred in 2% or more of patients
treated with adjunctive aripiprazole tablets (doses of 15 or 30 mg/day) and
lithium or valproate and for which the incidence in patients treated with this
combination was greater than the incidence in patients treated with placebo
plus lithium or valproate.

The following findings are based on a pool of two
placebo-controlled trials of patients with major depressive disorder in which
aripiprazole tablets were administered at doses of 2 mg to 20 mg as adjunctive
treatment to continued antidepressant therapy.

The incidence of discontinuation due to adverse reactions
was 6% for adjunctive aripiprazole-treated patients and 2% for adjunctive
placebo-treated patients.

The commonly observed adverse reactions associated with
the use of adjunctive aripiprazole tablets in patients with major depressive
disorder (incidence of 5% or greater and aripiprazole tablets incidence at least
twice that for placebo) were: akathisia, restlessness, insomnia, constipation,
fatigue, and blurred vision.

Table 12 enumerates the pooled incidence, rounded to the
nearest percent, of adverse reactions that occurred during acute therapy (up to
6 weeks), including only those adverse reactions that occurred in 2% or more of
patients treated with adjunctive aripiprazole tablets (doses ≥2 mg/day)
and for which the incidence in patients treated with adjunctive aripiprazole
tablets was greater than the incidence in patients treated with adjunctive
placebo in the combined dataset.

aAdverse reactions reported by at least 2% of
patients treated with adjunctive aripiprazole tablets, except adverse reactions
which had an incidence equal to or less than placebo.
*Antidepressant Therapy

Dose-Related Adverse Reactions In Patients With Schizophrenia

Dose response relationships for the incidence of
treatment-emergent adverse events were evaluated from four trials in adult
patients with schizophrenia comparing various fixed doses (2, 5, 10, 15, 20,
and 30 mg/day) of oral aripiprazole to placebo. This analysis, stratified by
study, indicated that the only adverse reaction to have a possible dose
response relationship, and then most prominent only with 30 mg, was somnolence
[including sedation]; (incidences were placebo, 7.1%; 10 mg, 8.5%; 15 mg, 8.7%;
20 mg, 7.5%; 30 mg, 12.6%).

Extrapyramidal Symptoms

Schizophrenia

In short-term, placebo-controlled trials in schizophrenia
in adults, the incidence of reported EPS-related events, excluding events
related to akathisia, for aripiprazole-treated patients was 13% vs. 12% for placebo;
and the incidence of akathisia-related events for aripiprazole-treated patients
was 8% vs. 4% for placebo.

Objectively collected data from those trials was
collected on the Simpson Angus Rating Scale (for EPS), the Barnes Akathisia
Scale (for akathisia), and the Assessments of Involuntary Movement Scales (for dyskinesias).
In the adult schizophrenia trials, the objectively collected data did not show
a difference between aripiprazole tablets and placebo, with the exception of
the Barnes Akathisia Scale (aripiprazole tablets, 0.08; placebo, –0.05).

Similarly, in a long-term (26-week), placebo-controlled
trial of schizophrenia in adults, objectively collected data on the Simpson
Angus Rating Scale (for EPS), the Barnes Akathisia Scale (for akathisia), and
the Assessments of Involuntary Movement Scales (for dyskinesias) did not show a
difference between aripiprazole tablets and placebo.

Bipolar Mania

In the short-term, placebo-controlled trials in bipolar
mania in adults, the incidence of reported EPS-related events, excluding events
related to akathisia, for monotherapy aripiprazole-treated patients was 16% vs.
8% for placebo and the incidence of akathisia-related events for monotherapy
aripiprazoletreated patients was 13% vs. 4% for placebo. In the 6-week,
placebo-controlled trial in bipolar mania for adjunctive therapy with lithium
or valproate, the incidence of reported EPS-related events, excluding events
related to akathisia for adjunctive aripiprazole-treated patients was 15% vs.
8% for adjunctive placebo and the incidence of akathisia-related events for
adjunctive aripiprazole-treated patients was 19% vs. 5% for adjunctive placebo.

In the adult bipolar mania trials with monotherapy
aripiprazole tablets, the Simpson Angus Rating Scale and the Barnes Akathisia
Scale showed a significant difference between aripiprazole tablets and placebo (aripiprazole
tablets, 0.50; placebo, –0.01 and aripiprazole tablets, 0.21; placebo, –0.05).
Changes in the Assessments of Involuntary Movement Scales were similar for the
aripiprazole tablets and placebo groups. In the bipolar mania trials with
aripiprazole tablets as adjunctive therapy with either lithium or valproate,
the Simpson Angus Rating Scale and the Barnes Akathisia Scale showed a
significant difference between adjunctive aripiprazole tablets and adjunctive
placebo (aripiprazole tablets, 0.73; placebo, 0.07 and aripiprazole tablets,
0.30; placebo, 0.11). Changes in the Assessments of Involuntary Movement Scales
were similar for adjunctive aripiprazole tablets and adjunctive placebo.

Major Depressive Disorder

In the short-term, placebo-controlled trials in major
depressive disorder, the incidence of reported EPSrelated events, excluding
events related to akathisia, for adjunctive aripiprazole-treated patients was
8% vs. 5% for adjunctive placebo-treated patients; and the incidence of
akathisia-related events for adjunctive aripiprazole-treated patients was 25%
vs. 4% for adjunctive placebo-treated patients.

In the major depressive disorder trials, the Simpson
Angus Rating Scale and the Barnes Akathisia Scale showed a significant
difference between adjunctive aripiprazole tablets and adjunctive placebo (aripiprazole
tablets, 0.31; placebo, 0.03 and aripiprazole tablets, 0.22; placebo, 0.02).
Changes in the Assessments of Involuntary Movement Scales were similar for the
adjunctive aripiprazole tablets and adjunctive placebo groups.

Dystonia

Symptoms of dystonia, prolonged abnormal contractions of
muscle groups, may occur in susceptible individuals during the first few days
of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes
progressing to tightness of the throat, swallowing difficulty, difficulty breathing,
and/or protrusion of the tongue. While these symptoms can occur at low doses,
they occur more frequently and with greater severity with high potency and at
higher doses of first generation antipsychotic drugs. An elevated risk of acute
dystonia is observed in males and younger age groups.

Skin Irritation For MYCITE Patch

Symptoms of skin irritation localized at the site of the
MYCITE Patch may occur in some patients. In clinical studies, sixty-one
patients (12.4%) experienced skin rashes localized at the site of patch placement.

The adverse reactions reported in a 26-week, double-blind
trial comparing oral aripiprazole and placebo in patients with schizophrenia
were generally consistent with those reported in the short-term,
placebocontrolled trials, except for a higher incidence of tremor [8% (12/153)
for aripiprazole tablets vs. 2% (3/153) for placebo]. In this study, the
majority of the cases of tremor were of mild intensity (8/12 mild and 4/12
moderate), occurred early in therapy (9/12 ≤49 days), and were of limited
duration (7/12 ≤10 days). Tremor led to discontinuation (<1%) of
aripiprazole tablets. In addition, in a long-term (52 week), active-controlled
study, the incidence of tremor was 5% (40/859) for aripiprazole tablets. A
similar profile was observed in a long-term monotherapy study and a long-term
adjunctive study with lithium and valproate in bipolar disorder.

Other Adverse Reactions Observed During The Premarketing
Evaluation Of Aripiprazole

Other adverse reactions associated with aripiprazole are
presented below. The listing does not include reactions: 1) already listed in
previous tables or elsewhere in labeling, 2) for which a drug cause was remote,
3) which were so general as to be uninformative, 4) which were not considered
to have significant clinical implications, or 5) which occurred at a rate equal
to or less than placebo.

Reactions are categorized by body system according to the
following definitions: frequent adverse reactions are those occurring in at
least 1/100 patients; infrequent adverse reactions are those occurring in 1/100
to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000
patients:

Postmarketing Experience

The following adverse reactions have been identified
during post-approval use of aripiprazole. Because these reactions are reported
voluntarily from a population of uncertain size, it is not always possible to reliably
estimate their frequency or establish a causal relationship to drug exposure:
occurrences of allergic reaction (anaphylactic reaction, angioedema,
laryngospasm, pruritus/urticaria, or oropharyngeal spasm), pathological
gambling, hiccups and blood glucose fluctuation.

The intensity of sedation was greater with the combination of oral aripiprazole and lorazepam as compared to that observed with aripiprazole alone. The orthostatic hypotension observed was greater with the combination as compared to that observed with lorazepam alone [see WARNINGS AND PRECAUTIONS]

Monitor sedation and blood pressure. Adjust dose accordingly.

Drugs Having No Clinically Important Interactions With ABILIFY
MYCITE

Based on pharmacokinetic studies, no dosage adjustment of
ABILIFY MYCITE is required when administered concomitantly with famotidine,
valproate, lithium, lorazepam.

Drug Abuse And Dependence

Controlled Substance

ABILIFY MYCITE is not a controlled substance.

Abuse

ABILIFY MYCITE has not been systematically studied in
humans for its potential for abuse, tolerance, or physical dependence.
Consequently, patients should be evaluated carefully for a history of drug
abuse, and such patients should be observed closely for signs of ABILIFY MYCITE
misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking
behavior).

Dependence

In physical dependence studies in monkeys, withdrawal
symptoms were observed upon abrupt cessation of dosing. While the clinical
trials did not reveal any tendency for any drug-seeking behavior, these observations
were not systematic and it is not possible to predict on the basis of this
limited experience the extent to which a CNS-active drug will be misused,
diverted, and/or abused once marketed.

WARNINGS

PRECAUTIONS

Elderly patients with dementia-related psychosis treated
with antipsychotic drugs are at an increased risk of death. Analyses of 17
placebo-controlled trials (modal duration of 10 weeks), largely in patients
taking atypical antipsychotic drugs, revealed a risk of death in drug-treated
patients of between 1.6 to 1.7 times the risk of death in placebo-treated
patients. Over the course of a typical 10-week controlled trial, the rate of
death in drug-treated patients was about 4.5%, compared to a rate of about 2.6%
in the placebo group.

Although the causes of death were varied, most of the
deaths appeared to be either cardiovascular (e.g., heart failure, sudden death)
or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar
to atypical antipsychotic drugs, treatment with conventional antipsychotic
drugs may increase mortality. The extent to which the findings of increased
mortality in observational studies may be attributed to the antipsychotic drug
as opposed to some characteristic(s) of the patients is not clear. ABILIFY
MYCITE is not approved for the treatment of patients with dementia-related
psychosis [see BOXED WARNING and Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with
Dementia-Related Psychosis].

Suicidal Thoughts And Behaviors In Pediatric And Young
Adult Patients

In pooled analyses of placebo-controlled trials of
antidepressant drugs (SSRIs and other antidepressant classes) that included
approximately 77,000 adult patients and over 4,400 pediatric patients, the
incidence of suicidal thoughts and behaviors in pediatric and young adult
patients was greater in antidepressanttreated patients than in placebo-treated
patients. The safety and efficacy of ABILIFY MYCITE have not been established
in pediatric patients [see Use In Specific Populations]. The
drug-placebo differences in the number of cases of suicidal thoughts and
behaviors per 1000 patients treated are provided in Table 3.

No suicides occurred in any of the pediatric studies.
There were suicides in the adult studies, but the number was not sufficient to
reach any conclusion about antidepressant drug effect on suicide.

Table 3: Risk Differences of the Number of Cases of
Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of
Antidepressants in Pediatric and Adult Patients

Age Range (years)

Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1000 Patients Treated

Increases Compared to Placebo

<18

14 additional patients

18-24

5 additional patients

Decreases Compared to Placebo

25-64

1 fewer patient

≥65

6 fewer patients

It is unknown whether the risk of suicidal thoughts and
behaviors in pediatric and young adult patients extends to longer-term use,
i.e., beyond four months. However, there is substantial evidence from placebo-controlled
maintenance trials in adults with MDD that antidepressants delay the recurrence
of depression.

Monitor all antidepressant-treated patients for clinical
worsening and emergence of suicidal thoughts and behaviors, especially during
the initial few months of drug therapy and at times of dosage changes. Counsel
family members or caregivers of patients to monitor for changes in behavior and
to alert the healthcare provider. Consider changing the therapeutic regimen,
including possibly discontinuing ABILIFY MYCITE, in patients whose depression
is persistently worse, or who are experiencing emergent suicidal thoughts or
behaviors.

The diagnostic evaluation of patients with this syndrome
is complicated. In arriving at a diagnosis, it is important to exclude cases
where the clinical presentation includes both serious medical illness (e.g., pneumonia,
systemic infection) and untreated or inadequately treated extrapyramidal signs
and symptoms (EPS). Other important considerations in the differential
diagnosis include central anticholinergic toxicity, heat stroke, drug fever,
and primary central nervous systempathology.

The management of NMS should include: 1) immediate
discontinuation of antipsychotic drugs and other drugs not essential to
concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and
3) treatment of any concomitant serious medical problems for which specific
treatments are available. There is no general agreement about specific
pharmacological treatment regimens for uncomplicated NMS.

If a patient requires antipsychotic drug treatment after
recovery from NMS, the potential reintroduction of drug therapy should be
carefully considered. The patient should be carefully monitored, since
recurrences of NMS have been reported.

Tardive Dyskinesia

A syndrome of potentially irreversible, involuntary,
dyskinetic movements may develop in patients treated with antipsychotic drugs,
including ABILIFY MYCITE. Although the prevalence of the syndrome appears to be
highest among the elderly, especially elderly women, it is impossible to rely
upon prevalence estimates to predict, at the inception of antipsychotic
treatment, which patients are likely to develop the syndrome. Whether
antipsychotic drug products differ in their potential to cause tardive dyskinesia
is unknown.

The risk of developing tardive dyskinesia and the
likelihood that it will become irreversible are believed to increase as the
duration of treatment and the total cumulative dose of antipsychotic drugs
administered to the patient increase. However, the syndrome can develop,
although much less commonly, after relatively brief treatment periods at low
doses.

The syndrome may remit, partially or completely, if
antipsychotic treatment is withdrawn. Antipsychotic treatment, itself, however,
may suppress (or partially suppress) the signs and symptoms of the syndrome and,
thereby, may possibly mask the underlying process. The effect that symptomatic
suppression has upon the long-term course of the syndrome is unknown.

Given these considerations, ABILIFY MYCITE should be
prescribed in a manner that is most likely to minimize the occurrence of
tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved
for patients who suffer from a chronic illness that (1) is known to respond to
antipsychotic drugs and (2) for whom alternative, equally effective, but
potentially less harmful treatments are not available or appropriate. In
patients who do require chronic treatment, the smallest dose and the shortest
duration of treatment producing a satisfactory clinical response should be
sought. The need for continued treatment should be reassessed periodically.

If signs and symptoms of tardive dyskinesia appear in a
patient on ABILIFY MYCITE, drug discontinuation should be considered. However,
some patients may require treatment with ABILIFY MYCITE despite the presence of
the syndrome.

Metabolic Changes

Atypical antipsychotic drugs have caused metabolic
changes that include hyperglycemia, diabetes mellitus, dyslipidemia, and body
weight gain. While all of the drugs in the class have been shown to produce
some metabolic changes, each drug has its own specific risk profile.

Hyperglycemia/Diabetes Mellitus

Hyperglycemia, in some cases extreme and associated with
ketoacidosis or hyperosmolar coma or death, has been reported in patients
treated with atypical antipsychotics. There have been reports of hyperglycemia
in patients treated with aripiprazole [see ADVERSE REACTIONS].
Assessment of the relationship between atypical antipsychotic use and glucose
abnormalities is complicated by the possibility of an increased background risk
of diabetes mellitus in patients with schizophrenia and the increasing
incidence of diabetes mellitus in the general population. Given these
confounders, the relationship between atypical antipsychotic use and hyperglycemia-related
adverse events is not completely understood. However, epidemiological studies
suggest an increased risk of hyperglycemiarelated adverse reactions in patients
treated with the atypical antipsychotics.

Patients with an established diagnosis of diabetes
mellitus who are started on atypical antipsychotics should be monitored
regularly for worsening of glucose control. Patients with risk factors for
diabetes mellitus (e.g., obesity, family history of diabetes) who are starting
treatment with atypical antipsychotics should undergo fasting blood glucose
testing at the beginning of treatment and periodically during treatment. Any
patient treated with atypical antipsychotics should be monitored for symptoms
of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness.
Patients who develop symptoms of hyperglycemia during treatment with atypical
antipsychotics should undergo fasting blood glucose testing. In some cases,
hyperglycemia has resolved when the atypical antipsychotic was discontinued;
however, some patients required continuation of anti-diabetic treatment despite
discontinuation of the atypical antipsychotic drug.

At 24 weeks, the mean change in fasting glucose in
aripiprazole-treated patients was not significantly different than in placebo-treated
patients [+2.2 mg/dL (n=42) and +9.6 mg/dL (n=28), respectively].

Weight Gain

Weight gain has been observed with atypical antipsychotic
use. Clinical monitoring of weight is recommended.

In an analysis of 13 placebo-controlled monotherapy
trials, primarily from pooled schizophrenia and bipolar disorder, with a median
exposure of 21 to 25 days, the mean change in body weight in aripiprazole-treated
patients was +0.3 kg (N=1673) compared to –0.1 kg (N=1100) in
placebo-controlled patients. At 24 weeks, the mean change from baseline in body
weight in aripiprazole-treated patients was –1.5 kg (n=73) compared to –0.2 kg
(n=46) in placebo-treated patients.

In the trials adding aripiprazole to antidepressants,
patients first received 8 weeks of antidepressant treatment followed by 6 weeks
of adjunctive aripiprazole or placebo in addition to their ongoing antidepressant
treatment. The mean change in body weight in patients receiving adjunctive
aripiprazole was +1.7 kg (N=347) compared to +0.4 kg (N=330) in patients
receiving adjunctive placebo.

Pathological Gambling And Other Compulsive Behaviors

Post-marketing case reports suggest that patients can
experience intense urges, particularly for gambling, and the inability to
control these urges while taking aripiprazole. Other compulsive urges, reported
less frequently, include: sexual urges, shopping, eating or binge eating, and
other impulsive or compulsive behaviors. Because patients may not recognize
these behaviors as abnormal, it is important for prescribers to ask patients or
their caregivers specifically about the development of new or intense gambling
urges, compulsive sexual urges, compulsive shopping, binge or compulsive
eating, or other urges while being treated with ABILIFY MYCITE. It should be
noted that impulse-control symptoms can be associated with the underlying
disorder. In some cases, although not all, urges were reported to have stopped
when the dose was reduced or the medication was discontinued. Compulsive
behaviors may result in harm to the patient and others if not recognized.
Consider dose reduction or stopping the medication if a patient develops such
urges.

The incidence of a significant orthostatic change in
blood pressure (defined as a decrease in systolic blood pressure ≥20 mmHg
accompanied by an increase in heart rate ≥25 bpm when comparing standing
to supine values) for aripiprazole was not meaningfully different from placebo
(aripiprazole incidence, placebo incidence) in adult oral aripiprazole-treated
patients (4%, 2%).

Falls

Antipsychotics, including ABILIFY MYCITE, may cause
somnolence, postural hypotension, motor and sensory instability, which may lead
to falls and, consequently, fractures or other injuries. For patients with diseases,
conditions, or medications that could exacerbate these effects, complete fall
risk assessments when initiating antipsychotic treatment and recurrently for
patients on long-term antipsychotic therapy.

Leukopenia, Neutropenia, And Agranulocytosis

In clinical trials and/or postmarketing experience,
events of leukopenia and neutropenia have been reported temporally related to
antipsychotic agents, including aripiprazole. Agranulocytosis has also been reported.

Possible risk factors for leukopenia/neutropenia include
pre-existing low white blood cell count (WBC)/absolute neutrophil count (ANC)
and history of drug-induced leukopenia/neutropenia. In patients with a history
of a clinically significant low WBC/ANC or drug-induced leukopenia/neutropenia,
perform a complete blood count (CBC) frequently during the first few months of
therapy. In such patients, consider discontinuation of ABILIFY MYCITE at the
first sign of a clinically significant decline in WBC in the absence of other
causative factors.

Monitor patients with clinically significant neutropenia
for fever or other symptoms or signs of infection and treat promptly if such
symptoms or signs occur. Discontinue ABILIFY MYCITE in patients with severe
neutropenia (absolute neutrophil count <1000/mm³) and follow their WBC
counts until recovery.

Seizures

In short-term, placebo-controlled trials, patients with a
history of seizures excluded seizures/convulsions occurred in 0.1% (3/2467) of
undiagnosed adult patients treated with oral aripiprazole.

As with other antipsychotic drugs, ABILIFY MYCITE should
be used cautiously in patients with a history of seizures or with conditions
that lower the seizure threshold. Conditions that lower the seizure threshold
may be more prevalent in a population of 65 years or older.

Potential For Cognitive And Motor Impairment

ABILIFY MYCITE, like other antipsychotics, has the
potential to impair judgment, thinking, or motor skills. In short-term,
placebo-controlled trials, somnolence (including sedation) was reported in 11%
of aripiprazole-treated patients compared with 6% of placebo-treated patients.
Somnolence (including sedation) led to discontinuation in 0.3% (8/2467) of
adult patients on oral aripiprazole in short-term, placebo-controlled trials.

Patients should be cautioned about operating hazardous
machinery, including automobiles, until they are reasonably certain that
therapy with ABILIFY MYCITE does not affect them adversely.

Body Temperature Regulation

Disruption of the body's ability to reduce core body
temperature has been attributed to antipsychotic agents. Appropriate care is
advised when prescribing ABILIFY MYCITE for patients who will be experiencing
conditions which may contribute to an elevation in core body temperature,
(e.g., exercising strenuously, exposure to extreme heat, receiving concomitant
medication with anticholinergic activity, or being subject to dehydration).

Dysphagia

Esophageal dysmotility and aspiration have been
associated with antipsychotic drug use, including aripiprazole. ABILIFY MYCITE
and other antipsychotic drugs should be used cautiously in patients at risk for
aspiration pneumonia.

Patient Counseling Information

General Instructions For Use

Instruct patients to refer to the app store to ensure
compatibility with their specific smartphone. Instruct patient to first download
the MYCITE APP and follow instructions provided by the app. Advise patients
that the initial use should be facilitated by the healthcare provider.

Advise patients that most ingestions will be detected
within 30 minutes; however, in some cases it can take over two hours for the
smartphone app and web portal to detect the ingestion of ABILIFY MYCITE. In
some cases, the ingestion of the tablet may not be detected. If the tablet is
not detected after ingestion, the dose should not be repeated.

Managing Lost Or Disabled Mobile Device

Advise patients that if their smartphone is lost,
impaired or otherwise rendered unusable, some information collected by the
system (synced) may be lost. Advise patients to change their MYCITE Patch immediately
and connect to a new mobile device using their current account information.
Information previously synced to the patients account will be available.

Using The MYCITE Patch In Different Environments

The MYCITE Patch will communicate with a paired device
when it is within 9-foot proximity. The MYCITE Patch should remain on an
individual whether they are showering, swimming, or exercising as it is
intended to tolerate water or perspiration. Patients undergoing an MRI,
however, need to remove their patch and replace with a new one as soon as
possible. In order for the MYCITE Patch to communicate with a smartphone, the
device must be powered on and Bluetooth®-enabled.

Suicidal Thoughts And Behaviors

Advise patients and caregivers to look for the emergence
of suicidality, especially early during treatment and when the dosage is
adjusted up or down and instruct them to report such symptoms to the healthcare
provider [see BOXED WARNING, WARNINGS AND PRECAUTIONS].

Neuroleptic Malignant Syndrome (NMS)

Counsel patients about a potentially fatal adverse
reaction referred to as Neuroleptic Malignant Syndrome (NMS) that has been
reported in association with administration of antipsychotic drugs. Advise
patients to contact a health care provider or report to the emergency room if
they experience signs or symptoms of NMS [see WARNINGS AND PRECAUTIONS].

Tardive Dyskinesia

Advise patients that abnormal involuntary movements have
been associated with the administration of antipsychotic drugs. Counsel
patients on the signs and symptoms of tardive dyskinesia and to contact their
health care provider if these abnormal movements occur [see WARNINGS AND
PRECAUTIONS].

Metabolic Changes

Educate patients about the risk of metabolic changes, how
to recognize symptoms of hyperglycemia and diabetes mellitus, and the need for
specific monitoring, including blood glucose, lipids, and weight [see WARNINGS
AND PRECAUTIONS].

Pathological Gambling And Other Compulsive Behaviors

Advise patients and their caregivers of the possibility
that they may experience compulsive urges to shop, increased urges to gamble,
compulsive sexual urges, binge eating and/or other compulsive urges and the inability
to control these urges while taking aripiprazole. In some cases, but not all,
the urges were reported to have stopped when the dose was reduced or stopped [see
WARNINGS AND PRECAUTIONS].

Orthostatic Hypotension And Syncope

Educate patients about the risk of orthostatic
hypotension and syncope especially early in treatment, when re-initiating
treatment, or when increasing the dosage [see WARNINGS AND PRECAUTIONS].

Leukopenia, Neutropenia And Agranulocytosis

Advise patients with a pre-existing low WBC or a history
of drug induced leukopenia/neutropenia that they should have their CBC
monitored while taking ABILIFY MYCITE [see WARNINGS AND PRECAUTIONS].

Interference With Cognitive And Motor Performance

Because ABILIFY MYCITE may have the potential to impair
judgment, thinking, or motor skills, patients should be cautioned about
operating hazardous machinery, including automobiles, until they are reasonably
certain that ABILIFY MYCITE therapy does not affect them adversely [see WARNINGS
AND PRECAUTIONS].

Heat Exposure And Dehydration

Concomitant Medication

Patients should be advised to inform their physicians if
they are taking, or plan to take, any prescription or over-the-counter drugs,
since there is a potential for interactions [see DRUG INTERACTIONS].

Pregnancy

Advise patients that ABILIFY MYCITE may cause
extrapyramidal and/or withdrawal symptoms in a neonate and to notify their
healthcare provider with a known or suspected pregnancy. Advise patients that there
is a pregnancy exposure registry that monitors pregnancy outcomes in women
exposed to ABILIFY MYCITE during pregnancy [see Use In Specific Populations].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenesis

Lifetime carcinogenicity studies were conducted in ICR
mice, Sprague-Dawley (SD) rats, and F344 rats. Aripiprazole was administered
for 2 years in the diet at doses of 1, 3, 10, and 30 mg/kg/day to ICR mice and
1, 3, and 10 mg/kg/day to F344 rats (0.2 to 5 times and 0.3 to 3 times the
maximum recommended human dose [MRHD] based on mg/m², respectively). In
addition, SD rats were dosed orally for 2 years at 10, 20, 40, and 60 mg/kg/day
(3 to 19 times the MRHD based on mg/m²). Aripiprazole did not induce tumors in
male mice or male rats. In female mice, the incidences of pituitary gland
adenomas and mammary gland adenocarcinomas and adenoacanthomas were increased
at dietary doses of 3 to 30 mg/kg/day (0.1 to 0.9 times human exposure at MRHD
based on AUC and 0.5 to 5 times the MRHD based on mg/m²). In female rats, the
incidence of mammary gland fibroadenomas was increased at a dietary dose of 10
mg/kg/day (0.1 times human exposure at MRHD based on AUC and 3 times the MRHD
based on mg/m²); and the incidences of adrenocortical carcinomas and combined
adrenocortical adenomas/carcinomas were increased at an oral dose of 60
mg/kg/day (14 times human exposure at MRHD based on AUC and 19 times the MRHD
based on mg/m²).

Proliferative changes in the pituitary and mammary gland
of rodents have been observed following chronic administration of other
antipsychotic agents and are considered prolactin-mediated. Serum prolactin was
not measured in the aripiprazole carcinogenicity studies. However, increases in
serum prolactin levels were observed in female mice in a 13-week dietary study
at the doses associated with mammary gland and pituitary tumors. Serum
prolactin was not increased in female rats in 4-week and 13- week dietary
studies at the dose associated with mammary gland tumors. The relevance for
human risk of the findings of prolactin-mediated endocrine tumors in rodents is
unknown.

Mutagenesis

The mutagenic potential of aripiprazole was tested in the
in vitro bacterial reverse-mutation assay, the in vitro bacterial DNA repair
assay, the in vitro forward gene mutation assay in mouse lymphoma cells, the in
vitro chromosomal aberration assay in Chinese hamster lung (CHL) cells, the in
vivo micronucleus assay in mice, and the unscheduled DNA synthesis assay in
rats. Aripiprazole and a metabolite (2,3- DCPP) were clastogenic in the in
vitro chromosomal aberration assay in CHL cells with and without metabolic
activation. The metabolite, 2,3-DCPP, produced increases in numerical
aberrations in the in vitro assay in CHL cells in the absence of metabolic
activation. A positive response was obtained in the in vitro micronucleus assay
in mice; however, the response was due to a mechanism not considered relevant to
humans.

Impairment Of Fertility

Female rats were treated with oral doses of 2, 6, and 20
mg/kg/day (0.6, 2, and 6 times the MRHD on a mg/m² basis) of aripiprazole from
2 weeks prior to mating through day 7 of gestation. Estrus cycle irregularities
and increased corpora lutea were seen at all doses, but no impairment of
fertility was seen.

Increased pre-implantation loss was seen at 6 and 20
mg/kg/day and decreased fetal weight was seen at 20 mg/kg/day.

Male rats were treated with oral doses of 20, 40, and 60
mg/kg/day (6, 13, and 19 times the MRHD on a mg/m² basis) of aripiprazole from
9 weeks prior to mating through mating. Disturbances in spermatogenesis were
seen at 60 mg/kg and prostateatrophy was seen at 40 and 60 mg/kg, but no impairment
of fertility was seen.

Use In Specific Populations

Pregnancy

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to ABILIFY MYCITE during pregnancy. For
more information contact the National Pregnancy Registry for Atypical Antipsychotics
at 1-866-961-2388 or visit
http://womensmentalhealth.org/clinical-and-researchprograms/ pregnancyregistry/.

Risk Summary

Neonates exposed to antipsychotic drugs, including ABILIFY
MYCITE, during the third trimester of pregnancy are at risk for extrapyramidal
and/or withdrawal symptoms [see Clinical Considerations]. There are no
available data on aripiprazole use in pregnant women to inform a
drug-associated risk of major birth defects and miscarriage. Animal
reproduction studies were conducted with aripiprazole in rats and rabbits
during organogenesis, and in rats during the pre-and post-natal period. Oral
and intravenous aripiprazole administration during organogenesis in rats and/or
rabbits at doses higher than the maximum recommended human dose (MRHD) produced
fetal death, decreased fetal weight, undescended testicles, delayed skeletal
ossification, skeletal abnormalities, and diaphragmatic hernia. Oral and
intravenous aripiprazole administration during the pre- and post-natal period
in rats at doses higher than the maximum recommended human dose (MRHD) produced
prolonged gestation, stillbirths, decreased pup weight, and decreased pup
survival. Consider the benefits and risks of ABILIFY MYCITE and possible risks
to the fetus when prescribing ABILIFY MYCITE to a pregnant woman. Advise
pregnant women of potential fetal risk.

The background risk of major birth defects and
miscarriage for the indicated population are unknown. In the U.S. general
population, the estimated background risk of major birth defects and
miscarriage in clinically recognized pregnancies is 2-4% and 15-20%,
respectively.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

Extrapyramidal and/or withdrawal symptoms, including
agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and
feeding disorder have been reported in neonates who were exposed to
antipsychotic drugs (including aripiprazole) during the third trimester of
pregnancy. These symptoms have varied in severity. Some neonates recovered
within hours or days without specific treatment; others required prolonged
hospitalization. Monitor neonates for extrapyramidal and/or withdrawal
symptoms.

Data

Pregnant rats were treated with oral doses of 3, 10, and
30 mg/kg/day (1, 3, and 10 times the maximum recommended human dose [MRHD] on a
mg/m² basis) of aripiprazole during the period of organogenesis. Gestation was
slightly prolonged at 30 mg/kg/day. Treatment at the high dose of 30 mg/kg/day
caused a slight delay in fetal development (decreased fetal weight),
undescended testes, and delayed skeletal ossification (also seen at 10
mg/kg/day). There were no adverse effects on embryofetal or pup survival.
Delivered offspring had decreased body weights (10 and 30 mg/kg/day), and
increased incidences of hepatodiaphragmatic nodules and diaphragmatic hernia at
30 mg/kg (the other dose groups were not examined for these findings).
Postnatally, delayed vaginal opening was seen at 10 and 30 mg/kg/day and
impaired reproductive performance (decreased fertility rate, corpora lutea,
implants, live fetuses, and increased post-implantation loss, likely mediated
through effects on female offspring) was seen at 30 mg/kg/day. Some maternal
toxicity was seen at 30 mg/kg/day however, there was no evidence to suggest
that these developmental effects were secondary to maternal toxicity.

In pregnant rats receiving aripiprazole injection
intravenously (3, 9, and 27 mg/kg/day) during the period of organogenesis,
decreased fetal weight and delayed skeletal ossification were seen at the
highest dose where it also caused maternal toxicity.

Pregnant rabbits were treated with oral doses of 10, 30,
and 100 mg/kg/day (2 , 3, and 11 times human exposure at MRHD based on AUC and
6, 19, and 65 times the MRHD based on mg/m²) of aripiprazole during the period
of organogenesis. At the high dose of 100 mg/kg/day decreased maternal food consumption,
and increased abortions were seen as well as increased fetal mortality,
decreased fetal weight (also seen at 30 mg/kg/day), increased incidence of a
skeletal abnormality (fused sternebrae) (also seen at 30 mg/kg/day).

In pregnant rabbits receiving aripiprazole injection
intravenously (3, 10, and 30 mg/kg/day) during the period of organogenesis, the
highest dose, which caused pronounced maternal toxicity, resulted in decreased
fetal weight, increased fetal abnormalities (primarily skeletal), and decreased
fetal skeletal ossification. The fetal no-effect dose was 10 mg/kg/day, which
is 5 times the human exposure at the MRHD based on AUC and is 6 times the MRHD
based on mg/m².

In a study in which rats were treated peri- and
post-natally with oral doses of 3, 10, and 30 mg/kg/day (1, 3, and 10 times the
MRHD on a mg/m² basis) of aripiprazole from gestation day 17 through day 21 postpartum,
slight maternal toxicity, slightly prolonged gestation an increase in stillbirths
and, decreases in pup weight (persisting into adulthood) and survival were seen
at 30 mg/kg/day.

In rats receiving aripiprazole injection intravenously
(3, 8, and 20 mg/kg/day) from gestation day 6 through day 20 postpartum, an
increase in stillbirths was seen at 8 and 20 mg/kg/day, and decreases in early
postnatal pup weights and survival were seen at 20 mg/kg/day; these effects
were seen in presence of maternal toxicity. There were no effects on postnatal
behavioral and reproductive development.

The effect of ABILIFY MYCITE on labor and delivery in
humans is unknown.

Lactation

Risk Summary

Aripiprazole is present in human breast milk; however,
there are insufficient data to assess the amount in human milk, the effects on
the breastfed infant, or the effects on milk production.

The development and health benefits of breastfeeding
should be considered along with the mother's clinical need for ABILIFY MYCITE
and any potential adverse effects on the breastfed infant from ABILIFY MYCITE
or from the underlying maternal condition.

Pediatric Use

Safety and effectiveness of ABILIFY MYCITE in pediatric
patients have not been established.

Geriatric Use

No dosage adjustment of ABILIFY MYCITE is recommended for
elderly patients for the approved indications [see BOXED WARNING, WARNINGS
AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Of the 13,543 patients treated with oral aripiprazole in
clinical trials, 1073 (8%) were ≥65 years old and 799 (6%) were ≥75
years old. Placebo-controlled studies of oral aripiprazole in schizophrenia,
bipolar mania, or major depressive disorder did not include sufficient numbers
of subjects aged 65 and over to determine whether they respond differently from
younger subjects.

Elderly patients with dementia-related psychosis treated
with antipsychotic drugs are at an increased risk of death. Elderly patients
treated with antipsychotic drugs with dementia-related psychosis had a greater incidence
of stroke and transient ischemic attack. ABILIFY MYCITE is not approved for the
treatment of elderly patients with dementia-related psychosis [see BOXED
WARNING and WARNINGS AND PRECAUTIONS].

CYP2D6 Poor Metabolizers

ABILIFY MYCITE dosage adjustment is recommended in known
CYP2D6 poor metabolizers due to high aripiprazole concentrations. Approximately
8% of Caucasians and 3–8% of Black/African Americans cannot metabolize CYP2D6
substrates and are classified as poor metabolizers (PM) [see DOSAGE AND
ADMINISTRATION and CLINICAL PHARMACOLOGY].

Hepatic And Renal Impairment

No dosage adjustment for ABILIFY MYCITE is required on
the basis of a patient's hepatic function (mild to severe hepatic impairment,
Child-Pugh score between 5 and 15), or renal function (mild to severe renal
impairment, glomerular filtration rate between 15 and 90 mL/minute) [see CLINICAL
PHARMACOLOGY].

Other Specific Populations

No dosage adjustment for ABILIFY MYCITE is required on
the basis of a patient's sex, race, or smoking status [see CLINICAL
PHARMACOLOGY].

OVERDOSE

Human Experience

In clinical trials and in postmarketing experience, adverse
reactions of deliberate or accidental overdosage with oral aripiprazole have
been reported worldwide. These include overdoses with oral aripiprazole alone
and in combination with other substances.

Management Of Overdosage

No specific information is available on the treatment of
overdose with ABILIFY MYCITE. If overexposure occurs call your poison control
center at 1-800-222-1222. An electrocardiogram should be obtained in case of
overdosage and if QT interval prolongation is present, cardiac monitoring
should be instituted. Otherwise, management of overdose should concentrate on
supportive therapy, maintaining an adequate airway, oxygenation and
ventilation, and management of symptoms. Close medical supervision and
monitoring should continue until the patient recovers.

Charcoal

In the event of an overdose of ABILIFY MYCITE, an early
charcoal administration may be useful in partially preventing the absorption of
aripiprazole. Administration of 50 g of activated charcoal, one hour after a
single 15 mg oral dose of aripiprazole, decreased the mean AUC and Cmax of aripiprazole
by 50%.

Hemodialysis

Although there is no information on the effect of
hemodialysis in treating an overdose with aripiprazole, hemodialysis is
unlikely to be useful in overdose management since aripiprazole is highly bound
to plasma proteins.

CLINICAL PHARMACOLOGY

Mechanism Of Action

The mechanism of action of aripiprazole in the treatment
of schizophrenia, bipolar 1 disorder, or adjunctive treatment of major
depressive disorder is unknown. However, the efficacy of aripiprazole could be
mediated through a combination of partial agonist activity at D2 and 5-HT1A
receptors and antagonist activity at 5-HT2A receptors.

Pharmacodynamics

Aripiprazole exhibits high affinity for dopamine D2 and
D3, serotonin 5-HT1A and 5-HT2A receptors (Ki values of 0.34 nM, 0.8 nM, 1.7
nM, and 3.4 nM, respectively), moderate affinity for dopamine D4, serotonin
5-HT2C and 5-HT7, alpha1-adrenergic and histamine H1 receptors (Ki values of 44
nM, 15 nM, 39 nM, 57 nM, and 61 nM, respectively), and moderate affinity for
the serotonin reuptake site (Ki=98 nM). Aripiprazole has no appreciable
affinity for cholinergic muscarinic receptors (IC50>1000 nM). Actions at
receptors other than D2, 5-HT1A, and 5-HT2A may explain some of the adverse
reactions of aripiprazole (e.g., the orthostatic hypotension observed with
aripiprazole may be explained by its antagonist activity at adrenergic alpha1
receptors).

Pharmacokinetics

Aripiprazole activity is presumably primarily due to the
parent drug, aripiprazole, and to a lesser extent, to its major metabolite,
dehydro-aripiprazole, which has been shown to have affinities for D2 receptors similar
to the parent drug and represents 40% of the parent drug exposure in plasma.
The mean elimination half-lives are about 75 hours and 94 hours for
aripiprazole and dehydro-aripiprazole, respectively. Steady-state
concentrations are attained within 14 days of dosing for both active moieties. Aripiprazole
accumulation is predictable from single-dose pharmacokinetics. At steady-state,
the pharmacokinetics of aripiprazole is dose-proportional. Elimination of
aripiprazole is mainly through hepatic metabolism involving two P450 isozymes,
CYP2D6 and CYP3A4. For CYP2D6 poor metabolizers, the mean elimination half-life
for aripiprazole is about 146 hours.

Absorption

Aripiprazole is well absorbed after administration of the
tablet, with peak plasma concentrations occurring within 3 hours to 5 hours;
the absolute oral bioavailability of the tablet formulation is 87%. ABILIFY
MYCITE can be administered with or without food. Administration of a 15 mg
aripiprazole tablet with a standard high-fat meal did not significantly affect
the Cmax or AUC of aripiprazole or its active metabolite, dehydro-aripiprazole,
but delayed Tmax by 3 hours for aripiprazole and 12 hours for dehydro-aripiprazole.

Distribution

The steady-state volume of distribution of aripiprazole
following intravenous administration is high (404 L or 4.9 L/kg), indicating
extensive extravascular distribution. At therapeutic concentrations, aripiprazole
and its major metabolite are greater than 99% bound to serum proteins,
primarily to albumin. In healthy human volunteers administered 0.5 to 30 mg/day
aripiprazole for 14 days, there was dosedependent D2 receptor occupancy
indicating brain penetration of aripiprazole in humans.

Elimination

Metabolism

Aripiprazole is metabolized primarily by three
biotransformation pathways: dehydrogenation, hydroxylation, and N-dealkylation.
Based on in vitro studies, CYP3A4 and CYP2D6 enzymes are responsible for
dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is
catalyzed by CYP3A4. Aripiprazole is the predominant drug moiety in the
systemic circulation. At steady-state, dehydro-aripiprazole, the active
metabolite, represents about 40% of aripiprazole AUC in plasma.

Excretion

Following a single oral dose of [14C]-labeled
aripiprazole, approximately 25% and 55% of the administered radioactivity was
recovered in the urine and feces, respectively. Less than 1% of unchanged aripiprazole
was excreted in the urine and approximately 18% of the oral dose was recovered
unchanged in the feces.

Drug Interaction Studies

Effects of other drugs on the exposures of aripiprazole
and dehydro-aripiprazole are summarized in Figure 1 and Figure 2, respectively.
Based on simulation, a 4.5-fold increase in mean Cmax and AUC values at
steady-state is expected when extensive metabolizers of CYP2D6 are administered
with both strong CYP2D6 and CYP3A4 inhibitors. A 3-fold increase in mean Cmax
and AUC values at steady-state is expected in poor metabolizers of CYP2D6
administered with strong CYP3A4 inhibitors.

Figure 1: The Effects of Other Drugs on Aripiprazole
Pharmacokinetics

Figure 2: The Effects of Other Drugs on
Dehydro-aripiprazole Pharmacokinetics

The effects of aripiprazole on the exposures of other
drugs are summarized in Figure 3. A population PK analysis in patients with
major depressive disorder showed no substantial change in plasma concentrations
of fluoxetine (20 or 40 mg/day), paroxetine CR (37.5 or 50 mg/day), or
sertraline (100 or 150 mg/day) dosed to steady-state. The steady-state plasma
concentrations of fluoxetine and norfluoxetine increased by about 18% and 36%,
respectively, and concentrations of paroxetine decreased by about 27%. The
steady-state plasma concentrations of sertraline and desmethylsertraline were
not substantially changed when these antidepressant therapies were
coadministered with aripiprazole.

Figure 3: The Effects of Aripiprazole on
Pharmacokinetics of Other Drugs

Specific Populations

Exposures of aripiprazole and dehydro-aripiprazole in
specific populations are summarized in Figure 4 and Figure 5, respectively.

Animal Toxicology And/Or Pharmacology

Aripiprazole produced retinal degeneration in albino rats
in a 26-week chronic toxicity study at a dose of 60 mg/kg and in a 2-year
carcinogenicity study at doses of 40 and 60 mg/kg. The 40 and 60 mg/kg/day doses
are 13 and 19 times the maximum recommended human dose (MRHD) based on mg/m²
and 7 to 14 times human exposure at MRHD based on AUC. Evaluation of the
retinas of albino mice and of monkeys did not reveal evidence of retinal
degeneration. Additional studies to further evaluate the mechanism have not
been performed. The relevance of this finding to human risk is unknown.

Clinical Studies

The safety and efficacy of aripiprazole tablets for the
treatment of adults with schizophrenia, acute treatment of adults with manic
and mixed episodes associated with Bipolar I disorder, and adjunctive treatment
of adults with major depressive disorder (MDD) has been established and is
based on the following adequate and well-controlled trials of aripiprazole
tablets:

Four short-term trials and one maintenance trial in adult
patients with schizophrenia [see Clinical Studies]

Four short-term monotherapy trials and one 6-week
adjunctive trial in adult patients with manic or mixed episodes [see Clinical
Studies]

One maintenance monotherapy trial and in one maintenance
adjunctive trial in adult patients with bipolar I disorder [see Clinical
Studies]

Two short-term trials in adult patients with MDD who had
an inadequate response to antidepressant therapy during the current episode [see
Clinical Studies]

Schizophrenia

The efficacy of aripiprazole tablets in the treatment of
schizophrenia was evaluated in five short-term (4- week and 6-week), placebo-controlled
trials of acutely relapsed inpatients who predominantly met DSMIII/ IV criteria
for schizophrenia. Four of the five trials were able to distinguish
aripiprazole tablets from placebo, but one study, the smallest, did not. Three
of these studies also included an active control group consisting of either
risperidone (one trial) or haloperidol (two trials), but they were not designed
to allow for a comparison of aripiprazole tablets and the active comparators.

In the four positive trials for aripiprazole tablets,
four primary measures were used for assessing psychiatric signs and symptoms.
Efficacy was evaluated using the total score on the Positive and Negative Syndrome
Scale (PANSS). The PANSS is a 30 item scale that measures positive symptoms of schizophrenia
(7 items), negative symptoms of schizophrenia (7 items), and general
psychopathology (16 items), each rated on a scale of 1 (absent) to 7 (extreme);
total PANSS scores range from 30 to 210. The

Clinical Global Impression (CGI) assessment reflects the
impression of a skilled observer, fully familiar with the manifestations of
schizophrenia, about the overall clinical state of the patient.

In a 4-week trial (n=414) comparing two fixed doses of
aripiprazole tablets (15 or 30 mg/day) to placebo, both doses of aripiprazole
tablets were superior to placebo in the PANSS total score (Study 1 in Table
14), PANSS positive subscale, and CGI-severity score. In addition, the 15 mg dose
was superior to placebo in the PANSS negative subscale.

In a 4-week trial (n=404) comparing two fixed doses of
aripiprazole tablets (20 or 30 mg/day) to placebo, both doses of aripiprazole
tablets were superior to placebo in the PANSS total score (Study 2 in Table
14), PANSS positive subscale, PANSS negative subscale, and CGI-severity score.

In a 6-week trial (n=420) comparing three fixed doses of
aripiprazole tablets (10, 15, or 20 mg/day) to placebo, all three doses of
aripiprazole tablets were superior to placebo in the PANSS total score (Study 3
in Table 14), PANSS positive subscale, and the PANSS negative subscale.

In a 6-week trial (n=367) comparing three fixed doses of
aripiprazole tablets (2, 5, or 10 mg/day) to placebo, the 10 mg dose of
aripiprazole tablets was superior to placebo in the PANSS total score (Study 4
in Table 14), the primary outcome measure of the study. The 2 and 5 mg doses
did not demonstrate superiority to placebo on the primary outcome measure.

Thus, the efficacy of 10, 15, 20, and 30 mg daily doses
was established in two studies for each dose. Among these doses, there was no
evidence that the higher dose groups offered any advantage over the lowest dose
group of these studies.

An examination of population subgroups did not reveal any
clear evidence of differential responsiveness on the basis of age, gender, or
race.

A longer-term trial enrolled 310 inpatients or
outpatients meeting DSM-IV criteria for schizophrenia who were, by history,
symptomatically stable on other antipsychotic medications for periods of 3
months or longer. These patients were discontinued from their antipsychotic
medications and randomized to aripiprazole tablets 15 mg/day or placebo for up
to 26 weeks of observation for relapse. Relapse during the double-blind phase
was defined as CGI-Improvement score of ≥5 (minimally worse), scores
≥5 (moderately severe) on the hostility or uncooperativeness items of the
PANSS, or ≥20% increase in the PANSS total score. Patients receiving
aripiprazole tablets 15 mg/day experienced a significantly longer time to
relapse over the subsequent 26 weeks compared to those receiving placebo (Study
5 in Figure 6).

Bipolar Disorder

Acute Treatment of Manic and Mixed Episodes

Monotherapy

The efficacy of aripiprazole tablets as monotherapy in
the acute treatment of manic and mixed episodes associated with bipolar I
disorder was established in four 3-week, placebo-controlled trials in
hospitalized patients who met the DSM-IV criteria for bipolar I disorder with
manic or mixed episodes. These studies included patients with or without
psychotic features and two of the studies also included patients with or without
a rapid-cycling course.

The primary instrument used for assessing manic symptoms
was the Young Mania Rating Scale (YMRS), an 11-item clinician-rated scale
traditionally used to assess the degree of manic symptomatology in a range from
0 (no manic features) to 60 (maximum score). A key secondary instrument
included the Clinical Global Impression-Bipolar (CGI-BP) Scale.

In the four positive, 3-week, placebo-controlled trials
(n=268; n=248; n=480; n=485) which evaluated aripiprazole tablets in a range of
15 mg to 30 mg, once daily (with a starting dose of 30 mg/day in two studies
and 15 mg/day in two studies), aripiprazole tablets were superior to placebo in
the reduction of YMRS total score (Studies 1-4 in Table 15) and CGI-BP Severity
of Illness score (mania). In the two studies with a starting dose of 15 mg/day,
48% and 44% of patients were on 15 mg/day at endpoint. In the two studies with
a starting dose of 30 mg/day, 86% and 85% of patients were on 30 mg/day at
endpoint.

Adjunctive Therapy

The efficacy of adjunctive aripiprazole tablets with
concomitant lithium or valproate in the treatment of manic or mixed episodes
associated with Bipolar I Disorder was established in a 6-week,
placebocontrolled study (n=384) with a 2-week lead-in mood stabilizer
monotherapy phase in adult patients who met DSM-IV criteria for bipolar I
disorder. This study included patients with manic or mixed episodes and with or
without psychotic features.

Patients were initiated on open-label lithium (0.6 to 1.0
mEq/L) or valproate (50 to 125 μg/mL) at therapeutic serum levels, and
remained on stable doses for 2 weeks. At the end of 2 weeks, patients demonstrating
inadequate response (Y-MRS total score ≥16 and ≤25% improvement on
the Y-MRS total score) to lithium or valproate were randomized to receive
either aripiprazole tablets (15 mg/day or an increase to 30 mg/day as early as
day 7) or placebo as adjunctive therapy with open-label lithium or valproate.
In the 6-week, placebo-controlled phase, adjunctive aripiprazole tablets
starting at 15 mg/day with concomitant lithium or valproate (in a therapeutic
range of 0.6 to 1.0 mEq/L or 50 to 125 μg/mL, respectively) was superior
to lithium or valproate with adjunctive placebo in the reduction of the Y-MRS total
score (Study 5 in Table 15) and CGI-BP Severity of Illness score (mania).
Seventy-one percent of the patients coadministered valproate and 62% of the
patients coadministered lithium were on 15 mg/day at 6-week endpoint.

Maintenance Treatment Of Bipolar I Disorder

Monotherapy Maintenance Therapy

A maintenance trial was conducted in adult patients
meeting DSM-IV criteria for bipolar I disorder with a recent manic or mixed
episode who had been stabilized on open-label aripiprazole tablets and who had maintained
a clinical response for at least 6 weeks. The first phase of this trial was an
open-label stabilization period in which inpatients and outpatients were
clinically stabilized and then maintained on open-label aripiprazole tablets
(15 or 30 mg/day, with a starting dose of 30 mg/day) for at least 6 consecutive
weeks. One hundred sixty-one outpatients were then randomized in a double-blind
fashion, to either the same dose of aripiprazole tablets they were on at the
end of the stabilization and maintenance period or placebo and were then
monitored for manic or depressive relapse. During the randomization phase,
aripiprazole tablets were superior to placebo on time to the number of combined
affective relapses (manic plus depressive), the primary outcome measure for
this study (Study 7 in Figure 7). A total of 55 mood events were observed
during the double-blind treatment phase. Nineteen were from the aripiprazole tablets
group and 36 were from the placebo group. The number of observed manic episodes
in the aripiprazole tablets group (6) were fewer than that in the placebo group
(19), while the number of depressive episodes in the aripiprazole tablets group
(9) was similar to that in the placebo group (11).

An examination of population subgroups did not reveal any
clear evidence of differential responsiveness on the basis of age and gender;
however, there were insufficient numbers of patients in each of the ethnic groups
to adequately assess inter-group differences.

Adjunctive Maintenance Therapy

An adjunctive maintenance trial was conducted in adult
patients meeting DSM-IV criteria for bipolar I disorder with a recent manic or
mixed episode. Patients were initiated on open-label lithium (0.6 to 1.0 mEq/L)
or valproate (50 to 125 μg/mL) at therapeutic serum levels, and remained
on stable doses for 2 weeks. At the end of 2 weeks, patients demonstrating
inadequate response (Y-MRS total score ≥16 and ≤35% improvement on
the Y-MRS total score) to lithium or valproate received aripiprazole tablets
with a starting dose of 15 mg/day with the option to increase to 30 mg or
reduce to 10 mg as early as day 4, as adjunctive therapy with open-label
lithium or valproate. Prior to randomization, patients on the combination of
single-blind aripiprazole tablets and lithium or valproate were required to
maintain stability (Y-MRS and MADRS total scores ≤12) for 12 consecutive
weeks. Three hundred thirty-seven patients were then randomized in a
double-blind fashion, to either the same dose of aripiprazole tablets they were
on at the end of the stabilization period or placebo plus lithium or valproate
and were then monitored for manic, mixed, or depressive relapse for a maximum
of 52 weeks. Aripiprazole tablets were superior to placebo on the primary
endpoint, time from randomization to relapse to any mood event (Study 8 in
Figure 8). A mood event was defined as hospitalization for a manic, mixed, or
depressive episode, study discontinuation due to lack of efficacy accompanied
by Y-MRS score >16 and/or a MADRS >16, or an SAE of worsening disease
accompanied by Y-MRS score >16 and/or a MADRS >16. A total of 68 mood
events were observed during the double-blind treatment phase. Twenty-five were
from the aripiprazole group and 43 were from the placebo group. The number of
observed manic episodes in the aripiprazole group (7) were fewer than that in
the placebo group (19), while the number of depressive episodes in the
aripiprazole group (14) was similar to that in the placebo group (18). The
Kaplan-Meier curves of the time from randomization to relapse to any mood event
during the 52-week, double-blind treatment phase for aripiprazole tablets and
placebo groups are shown in Figure 8.

An examination of population subgroups did not reveal any
clear evidence of differential responsiveness on the basis of age and gender;
however, there were insufficient numbers of patients in each of the ethnic groups
to adequately assess inter-group differences.

Adjunctive Treatment Of Adults With Major Depressive Disorder

The efficacy of aripiprazole tablets in the adjunctive
treatment of major depressive disorder (MDD) was demonstrated in two short-term
(6-week), placebo-controlled trials of adult patients meeting DSM-IV criteria
for MDD who had had an inadequate response to prior antidepressant therapy (1
to 3 courses) in the current episode and who had also demonstrated an
inadequate response to 8 weeks of prospective antidepressant therapy
(paroxetine extended-release, venlafaxine extended-release, fluoxetine, escitalopram,
or sertraline). Inadequate response for prospective treatment was defined as
less than 50% improvement on the 17-item version of the Hamilton Depression
Rating Scale (HAMD17), minimal HAMD17 score of 14, and a Clinical Global
Impressions Improvement rating of no better than minimal improvement.
Inadequate response to prior treatment was defined as less than 50% improvement
as perceived by the patient after a minimum of 6 weeks of antidepressant
therapy at or above the minimal effective dose.

The primary instrument used for assessing depressive
symptoms was the Montgomery-Asberg Depression Rating Scale (MADRS), a 10-item
clinician-rated scale used to assess the degree of depressive symptomatology.
The key secondary instrument was the Sheehan Disability Scale (SDS), a 3-item
selfrated instrument used to assess the impact of depression on three domains
of functioning with each item scored from 0 (not at all) to 10 (extreme).

In the two trials (n=381, n=362), aripiprazole tablets
were superior to placebo in reducing mean MADRS total scores (Studies 1, 2 in
Table 16). In one study, aripiprazole tablets were also superior to placebo in reducing
the mean SDS score.

In both trials, patients received aripiprazole tablets
adjunctive to antidepressants at a dose of 5 mg/day. Based on tolerability and
efficacy, doses could be adjusted by 5 mg increments, one week apart. Allowable
doses were: 2, 5, 10, 15 mg/day, and for patients who were not on potent CYP2D6
inhibitors fluoxetine and paroxetine, 20 mg/day. The mean final dose at the end
point for the two trials was 10.7 and 11.4 mg/day.

An examination of population subgroups did not reveal
evidence of differential response based on age, choice of prospective
antidepressant, or race. With regards to gender, a smaller mean reduction on
the MADRS total score was seen in males than in females.

PATIENT INFORMATION

If you are taking ABILIFY MYCITE with other medicines
for treatment of major depressive disorder (MDD), you should also read the
Medication Guides or Patient Information that comes with the other medicines.

MYCITE Patch (wearable sensor) that picks up (detects)
the signal from the IEM sensor after you take the ABILIFY MYCITE tablet and
sends the information to a smartphone.

MYCITE APP, which is a smartphone application (app) that
is used with a compatible smartphone to show information about when you take
your ABILIFY MYCITE tablet.

Web-based portal for healthcare providers and caregivers.

Download the MYCITE APP before using the ABILIFY
MYCITE System. Always follow the instructions provided within the MYCITE APP
when using the ABILIFY MYCITE System.

Your healthcare provider should show you how to use
the ABILIFY MYCITE System before you use it for the first time.

What is the most important information I should know
about ABILIFY MYCITE?

ABILIFY MYCITE may cause serious side effects,
including:

Increased risk of death in elderly people with
dementia-related psychosis. Medicines like ABILIFY MYCITE can raise the
risk of death in elderly people who have lost touch with reality (psychosis)
due to confusion and memory loss (dementia). ABILIFY MYCITE is not approved for
the treatment of people who have lost touch with reality (psychosis) due to
confusion or memory loss (dementia).

Increased risk of suicidal thoughts or actions in
children and young adults.Antidepressant medicines may increase suicidal
thoughts or actions in some children and young adults within the first few
months of treatment and when the dose is changed. It is not known if ABILIFY
MYCITE is safe and effective for use in children.

How can I watch for and try to prevent suicidal
thoughts and actions in myself or a family member?

Pay close attention to any changes, especially sudden
changes, in mood, behaviors, thoughts, or feelings. This is very important when
an antidepressant medicine is started or when the dose is changed.

Call the healthcare provider right away to report new or
sudden changes in mood, behavior, thoughts, or feelings.

Keep all follow-up visits with the healthcare provider as
scheduled. Call the healthcare provider between visits as needed, especially if
you have concerns about symptoms.

What is ABILIFY MYCITE?

ABILIFY MYCITE is a prescription medicine of aripiprazole
tablets with an Ingestible Event Marker (IEM) sensor inside it used:

short-term (acute) treatment of adults with manic or
mixed episodes alone or when used with the medicine lithium or valproate

maintenance treatment of adults alone or when used with
the medicine lithium or valproate

To treat adults with major depressive disorder (MDD)
along with other antidepressant medicines

The ABILIFY MYCITE System is meant to track if you have
taken your ABILIFY MYCITE.

It is not known if ABILIFY MYCITE can improve how well
you take your aripiprazole (patient compliance) or for changing your dose of
aripiprazole.

There may be a delay in the detection of the ABILIFY
MYCITE tablet and sometimes the detection of the tablet might not happen at
all. ABILIFY MYCITE is not for use as real-time or emergency monitoring.

It is not known if ABILIFY MYCITE is safe or effective
for use in children.

Do not take ABILIFY MYCITE if you are allergic to
aripiprazole or any of the ingredients in ABILIFY MYCITE. See the end of this
Medication Guide for a complete list of ingredients in ABILIFY MYCITE.

Before taking ABILIFY MYCITE, tell your healthcare
provider about all your medical conditions, including if you:

have diabetes or high blood sugar or have a family
history of diabetes or high blood sugar. Your healthcare provider should check
your blood sugar before you start and during treatment with ABILIFY MYCITE.

are pregnant or plan to become pregnant. Talk to your
healthcare provider about the risk to your unborn baby if you take ABLIFY
MYCITE during pregnancy.

Tell your healthcare provider if you become pregnant or
think you are pregnant during treatment with ABILIFY MYCITE.

If you become pregnant during treatment with ABILIFY
MYCITE, talk to your healthcare provider about registering with the National
Pregnancy Registry for Atypical Antipsychotics. You can register by calling
1-866- 961-2388 or go to
http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.

are breastfeeding or plan to breastfeed. ABILIFY MYCITE
can pass into your breast milk. Talk to your healthcare provider about the best
way to feed your baby during treatment with ABILIFY MYCITE.

Tell your healthcare provider about all the medicines
that you take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.

ABILIFY MYCITE and other medicines may affect each other
causing possible serious side effects. ABILIFY MYCITE may affect the way other
medicines work, and other medicines may affect how ABILIFY MYCITE works.

Your healthcare provider can tell you if it is safe to
take ABILIFY MYCITE with your other medicines. Do not start or stop any other
medicines during treatment with ABILIFY MYCITE without talking to your
healthcare provider first.

Know the medicines you take. Keep a list of your
medicines to show your healthcare provider and pharmacist when you get a new
medicine.

How should I take ABILIFY MYCITE?

See the MYCITE APP for instructions about how to apply
and wear the MYCITE Patch and how to use the ABILIFY MYCITE System the right
way.

Take ABILIFY MYCITE exactly as your healthcare provider
tells you to take it. Do not change the dose or stop taking ABILIFY MYCITE
without first talking to your healthcare provider.

The ABILIFY MYCITE tablet is usually detected within 30
minutes after you take it, but there may be a delay of more than 2 hours for
the smartphone app and web portal to detect that you have taken ABILIFY MYCITE,
and sometimes the ABILIFY MYCITE tablet might not be detected at all. If the
tablet is not detected after you take it, do not repeat the dose.

If over-exposure occurs, call your poison control center
at 1-800-222-1222.

What should I avoid while taking ABILIFY MYCITE?

Do not drive, operate heavy machinery, or do other
dangerous activities until you know how ABILIFY MYCITE affects you. ABILIFY
MYCITE may make you drowsy.

Do not become too hot or dehydrated during treatment with
ABILIFY MYCITE.

Do not exercise too much.

In hot weather, stay inside in a cool place if possible.

Stay out of the sun.

Do not wear too much clothing or heavy clothing.

Drink plenty of water.

What are the possible side effects of ABILIFY MYCITE?

ABILIFY MYCITE may cause serious side effects,
including:

See “What is the most important information I should
know about ABILIFY MYCITE?”

Stroke (cerebrovascular problems) in elderly people
with dementia-related psychosis that can lead to death.

Neuroleptic malignant syndrome (NMS), a serious
condition that can lead to death. Call your healthcare provider or go to the
nearest hospital emergency room right away if you have some or all of the
following signs and symptoms of NMS:

Uncontrolled body movements (tardive dyskinesia).
ABILIFY MYCITE may cause movements that you cannot control in your face,
tongue, or other body parts. Tardive dyskinesia may not go away, even if you
stop taking ABILIFY MYCITE. Tardive dyskinesia may also start after you stop
taking ABILIFY MYCITE.

Problems with your metabolism such as:

high blood sugar (hyperglycemia) and diabetes.
Increases in blood sugar can happen in some people who take ABILIFY MYCITE.
Extremely high blood sugar can lead to coma or death. If you have diabetes or
risk factors for diabetes (such as being overweight or a family history of
diabetes), your healthcare provider should check your blood sugar before you
start and during your treatment with ABILIFY MYCITE.Call your healthcare provider if you have any of these
symptoms of high blood sugar during treatment with ABILIFY MYCITE:

Unusual urges. Some people taking ABILIFY MYCITE
have had unusual urges, such as gambling, binge eating or eating that you
cannot control (compulsive), compulsive shopping and sexual urges. If you or
your family members notice that you are having unusual urges or behaviors, talk
to your healthcare provider.

Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or
lying position.

Falls

Low white blood cell count. Your healthcare
provider may do blood tests during the first few months of treatment with
ABILIFY MYCITE.

Seizures (convulsions)

Problems controlling your body temperature so that you
feel too warm. See “What should I avoid while taking ABILIFY MYCITE?”

General information about the safe and effective use
of ABILIFY MYCITE.

Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use ABILIFY

MYCITE for a condition for which it was not prescribed.
Do not give ABILIFY MYCITE to other people, even if they have the same symptoms
you have. It may harm them. You can ask your healthcare provider or pharmacist
for information about ABILIFY MYCITE that was written for healthcare
professionals.